AB0555 CHARACTERISTICS OF PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AT THE START OF BIOLOGICAL THERAPY AND AT FIRST FOLLOW-UP
Authors: A. D. Bilous, M. M. Tamas, I. Mihus, C. Pamfil, I. Felea, L. Damian, L. Muntean, I. Filipescu, I. Szabo, S. P. Simon, S. Rednic
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by heterogeneity of clinical manifestations ranging from mild skin and joint disease to severe, organ or life-threatening manifestations. It has an unpredictable tendency to flare up. Given the complex pathogenesis of SLE, involving both the adaptive and innate immune systems, the efficacy of steroids, antimalarials and immunosuppressants is limited in some cases, highlighting the need for new therapies with a targeted mechanism of action. Belimumab (BEL) is approved as an add-on therapy for active LES with positive autoantibodies despite standard treatment, while Rituximab (RTX) remains for off-label use in severe manifestations in many European countries. <h3>Objectives</h3> The aim of the current study is to describe the characteristics of SLE patients receiving biologic therapy with Belimumab or Rituximab at baseline and at first follow-up visit in a tertiary rheumatology center. <h3>Methods</h3> We retrospectively analyzed the electronic medical records of patients with SLE who started treatment with BEL and/or RTX. Demographic, clinical and paraclinical data as well as disease activity score at the time of starting treatment with biologics and at first follow-up visit were collected. <h3>Results</h3> Eighteen SLE patients were analyzed: 88.88% female, mean age at diagnosis 32±15 years, mean disease duration 7±5 years. The first follow-up visit was performed between 4 to 6 months after baseline. Eleven (61.1%) patients were treated with BEL, 5 (27.77%) RTX and 2 (11.11%) with both BEL and RTX. Hydroxychloroquine (HQ) was co-prescribed with biologics in 16/18 patients (88.88%). Azathioprine was prescribed in 6 patients (33.33%) and mycophenolate mofetil in 4 patients (22.22%). At the start of the biological treatment, all patients received steroids with a mean dose of 20±17 mg prednisone/day. One patient was able to discontinue the steroid, while in the others the mean prednisone dose decreased to 8.5±4.8 mg/day after 4-6 months. RTX was prescribed in 5 (71.42%) patients for lupus nephritis. All patients previously received cyclophosphamide. In one case, RTX was prescribed for severe thrombocytopenia, in another because of an overlap with active rheumatoid arthritis. Belimumab was prescribed in patients with more pronounced constitutional, articular, cutaneous and hematological features and mild renal involvement. In one case, BEL was prescribed for lupic enteritis. The mean SLEDAI score before starting treatment with the biologic was 12±3; the mean SLEDAI score at the first follow-up visit was 3±2.Anti-double-stranded DNA antibodies were positive in 16 (88.88%). At the time of initiating treatment with biologics and at follow-up, C3 hypocomplementemia was present in 13 (81.25%) and 8 (50%) patients, while C4 hypocomplementemia in 8 (50%) and 5 (31.25%) respectively. No serious adverse events were reported. One patient discontinued BEL due to inefficacy. <h3>Conclusion</h3> Biological therapy has been shown to control the disease activity and to reduce the need for steroids in SLE patients. RTX was used in patients with more severe manifestations such as lupus nephritis and severe thrombocytopenia. <h3>References</h3> [1]Fanouriakis, A. et al. (2021) Update οn the diagnosis and management of systemic lupus erythematosus, Annals of the Rheumatic Diseases. BMJ Publishing Group Ltd. Available at: https://ard.bmj.com/content/80/1/14 (accessed 12 January 2023). [2]Blair, H.A. and Duggan, S.T. (2018) "Belimumab: A review in systemic lupus erythematosus," Drugs, 78(3), pp. 355-366. Available at: https://doi.org/10.1007/s40265-018-0872-z. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.